Kornimate/medical-research-clean huggingface dataset:
clinical and radiographical assessment of patients with sub-condylar fracture using polyetheretherketone (peek) trapezoidal plates versus titanium trapezoidal plates

Conditions: Condylar Neck Fractures; Polyetheretherketone; Mandible Fracture

Summary: some of titanium's drawbacks that is commonly used in maxillofacial surgery included scatter artefacts on regular imaging, implant exposure and inflammation, high thermal conductivity, and high elastic modulus. very few clinical studies have been published on using a peek plate in the mandibular fractures and to the best of the author's knowledge, this is the first study that will be done comparing trapezoidal condylar 3d printed peek plates and titanium trapezoidal condylar plate in subcondylar fractures in terms of clinical and radiographical outcomes.

mandibular subcondylar fractures are common injuries that require treatment to restore function and aesthetic. titanium plates have long been the gold standard for fixation in these fractures due to their strength, durability, and ability to provide rigid stabilization. however, they are associated with limitations such as a higher elastic modulus than bone, imaging artifacts (e.g., ct or mri interference), and hardware-related complications. these drawbacks have prompted interest in alternative materials like polyetheretherketone (peek). peek is a novel biomaterial with promising properties, including biocompatibility, a modulus of elasticity closer to bone, and reduced imaging artifacts. these characteristics suggest it may mitigate some of the challenges associated with titanium plates. the improved elasticity of peek could reduce stress shielding and enhance functional recovery, while its imaging compatibility could simplify postoperative assessments. researchers have shown significant interest in the application of peek composites in trauma plating systems, total replacement implants, and tissue scaffolds, highlighting its potential as a versatile biomaterial. despite these advantages, evidence specifically evaluating peek trapezoidal plates for subcondylar fractures remains scarce, there are a no clinical studies directly comparing the outcomes of peek and titanium trapezoidal plates in terms of clinical outcomes. conducting a study to evaluate these two materials would provide valuable evidence to guide material selection in mandibular subcondylar fracture management.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older, irrespective of gender * recent mandibular subcondylar fractures indicated for open reduction and internal fixation exclusion criteria: * medically compromised patients contradicting operation (asa iii, iv \& v). * patients receiving radiotherapy or chemotherapy. * infection at the fracture line. * pathological fractures and old fractures * comminuted fractures

Keywords: peek plates trapezoidal plates cad/cam
topical bimatoprost in the treatment of migraine

Conditions: Migraine Disorders; Headache Disorders

Summary: the study is to assess the effectiveness of topically applied bimatoprost in reducing migraine headache frequency, severity, and duration. it will also assess the effect of topical bimatoprost on quality of life.

hall, et al. have observed retrospectively that treatment with topical prostaglandin f2 alpha analogs (applied either to the eye or fingernail bed) significantly reduced the frequency, severity and duration of headaches in migraine sufferers, as well as their migraine disability assessment score (midas). this is a double-blind, placebo-controlled prospective clinical study to determine if the effect of fda-approved bimatoprost, a prostaglandin f2 alpha analogue, has anti-migraine activity when administered topically to people suffering from migraine.

Eligibility criteria:
inclusion criteria: * diagnosis of migraines based on international classification of headache disorders (ichd) ii criteria and experiencing headaches for 4 or more days per month. exclusion criteria: * significant liver or renal dysfunction, * on treatment for inflammatory bowel disease, medication over-use for headaches according to the ichd ii criteria, * use of antipsychotics in the past month, * recent (in the past six months) history of alcohol or drug abuse, * allergy to bimatoprost and its compounds, * severe comorbid psychiatric illness, * severe infection, * malignancy, * severe cardiovascular disease, * neurodegenerative disorders, * pregnancy and lactation, and * sexually active women of child bearing age who do not use any method of contraception.

Keywords: migraine headache bimatoprost
diagnostic instruments for autism in deaf children study

Conditions: Hearing Loss; ASD

Summary: the trial is in three stages and will translate and validate screening and assessment instruments for use with deaf children. the first stage is modifying the screening and assessment instruments (adi-r and ados-2) for use with deaf children. this will involve choosing the most promising screening instrument (srs-2) based on the systematic review and the expertise of a review panel, which contains experts and public and patient involvement (ppi). this phase of the study seeks a wide range of user (parents/ carers and young people) views and experiences about the symptomatology and presentation of deaf children with autism, comparing this to hearing children with autism, and deaf children without autism. the second stage is to ensure that the newly modified instruments are accessible to deaf children and deaf parents by making any necessary translations from english into british sign language. this involves a strict translation and back translation methodology with reiterations until successful translation is achieved. for stage three in order to ensure that the new questionnaires are successfully identifying children and young people with autism spectrum disorder, the modified instrument will be validated using a 'gold standard'. the current 'gold standard' for the mental health screening of deaf children is a clinical interview administered by experienced senior multidisciplinary deaf child mental health clinicians.


Eligibility criteria:
inclusion criteria: for the purposes of this study, children and young people will be recruited if they have a chronological age of ≥18 months old, up to 18 years. deaf children will have a hearing loss of at least 40db exclusion criteria: this is a pragmatic trial which recognises the frequency and complexity of co-morbidities in children with autistic spectrum disorders (asd) and deafness. we will therefore not exclude on the basis of co-morbidity in the groups where a diagnosis of asd already exists, since these tools would be used with this population if adopted more widely in the nhs. we will not exclude children or young people with language delay as children with asd may have severe language delay. families where the parents do not have either a signed language being studied here, or a language in which the adi-r is available, will not be included.
efficacy and safety of dwc20155/dwc20156 combination therapy in patients with gastritis

Conditions: Gastritis

Summary: the purpose of this study is to evaludate the efficacy and safety of dwc20155/dwc20156 combination therapy in patients with gastritis


Eligibility criteria:
inclusion criteria: * male of female of at least 19 years old * patients diagnosed with acute or chronic gastritis by gastroscopy * patients with one or more erosions found by gastroscopy exclusion criteria: * patients with peptic ulcer and gastroesophageal reflux disease * patients with previous gastrointestinal surgery * patients with history of gastrointestinal cancer
resorbable polymer plates in repair of blowout orbital floor fractures

Conditions: Post-Traumatic Orbital Deformity

Summary: it is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.


Eligibility criteria:
inclusion criteria: * class i, ii blowout floor fracture. * presented within 2 weeks of trauma. * have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus. exclusion criteria: * comminuted orbital fractures involving the rim. * associated globe injuries. * delayed presentation.

Keywords: resorbable, blow out fractures
chinese herbal formula for covid-19

Conditions: Covid19

Summary: this is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate a 21-herb formula named modified qing fei pai du tang (mqfpd) to treat covid-19-positive outpatients with mild-to-moderate symptoms assigned to self-quarantined and home management. this the study aims to establish the safety and feasibility of the use of mqfpd vs placebo in 66 total subjects. subsequent trials will evaluate other therapeutics as well as the efficacy of mqfpd in a larger study population.

study participants will be assigned to one of two groups, either placebo or mqfpd. participants will be screened and consented remotely. both groups will receive blood draws at days 1 and 14, and will be sent study medication directly to their home from the investigational pharmacy. baseline and end-of-study laboratory draws will be done at home via mobile phlebotomy. adverse events and symptoms scores will be monitored by entry into a daily diary along with regular phone calls with the study coordinators. at the end of the study, safety will be assessed by laboratory measures and adverse event reporting.

Eligibility criteria:
inclusion criteria: * positive covid-19 diagnosis within the prior 72 hours or within 9 days of symptom onset * age 18 years and older * women of childbearing potential must have a negative urine or serum hcg. * women of childbearing potential must have a negative serum pregnancy test at screening and agree to use contraception throughout the study period. * capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team * willing to try to minimize alcohol, cannabis, and dairy products during the study period. exclusion criteria: 1. any of the following symptoms which, according to the cdc, require hospitalization: 1. trouble breathing 2. persistent pain or pressure in the chest 3. new confusion or inability to arouse 4. bluish lips or face 2. current use of investigational agents to prevent or treat covid-19 3. known liver disease (alt/ast \>3x uln or diagnosis of cirrhosis) 4. known renal disease (egfr \< 60 ml/min) or acute nephritis. 5. uncontrolled hypertension (sbp\>140 or dbp\>90 while on medications) 6. allergy to tree nuts 7. bleeding dyscrasia or on anticoagulation (aspirin and/or clopidogrel is allowed) 8. pregnant or breastfeeding women 9. use of tolbutamide 10. use of systemic corticosteroids (hydrocortisone, cortisone, prednisolone, betamethasone, methylprednisolone, prednisone, dexamethasone). inhaled budesonide is to be allowed. 11. use of digoxin 12. use of oxacillin 13. use of interferon 14. use of vincristine 15. use of cyclosporine 16. use of amiodarone 17. patients with a past medical history of epilepsy 18. use of monoamine oxidase inhibitors (maoi) 19. use of methamphetamine within the prior 30 days 20. use of cocaine within the prior 30 days 21. use of aminoglycosides, carbamazepine, flecainide, lithium, phenytoin, phenobarbital, rifampicin, theophylline and warfarin
efficacy and safety of liver transplantation for hepatocellular carcinoma with bile duct tumor thrombus: a single-arm, multicenter, prospective study (hcc-bdtt in lt)

Conditions: Liver Transplant; Hepatocellular Carcinoma; Bile Duct Tumor Thrombus

Summary: the prognosis for patients diagnosed with hepatocellular carcinoma with bile duct tumor thrombus (bdtt-hcc) remains notably grim, as there are presently no universally accepted treatment guidelines in place to address this complex condition. long-term outcomes of liver transplantation (lt) for bdtt-hcc are unclear, whether lt is a proper therapeutic option for bdtt-hcc patients remains to be determined. therefore, we designed a clinical trial to evaluate survival of bdtt-hcc patients in lt. this is an open-labeled, single-arm, prospective, multicenter and real-world study designed to assess the survival outcomes of bdtt-hcc patients in lt. patients will be enrolled based on histological confirmation of hcc with bdtt. the study will span a total of 4 years, including a 2-year enrollment phase and a subsequent 2-year follow-up period. we anticipate that lt will provide favorable survival benefits for bdtt-hcc patients, particularly in the key indicator recurrence-free survival (rfs) and improved quality of life. upon successful completion of the trial, we will extend our monitoring over a longer follow-up time to accurately estimate important indicators such as overall survival (os). we expect that this study will provide substantial evidence to refine treatment guidelines through thorough data analysis, ultimately contributing to better patient outcomes and advancing our understanding of the disease.


Eligibility criteria:
inclusion criteria: (1) age between 18 and 70 years; (2) postoperative pathological diagnosis of hcc with bdtt requiring lt; (3) the general condition can tolerate the operation; (4) written informed consent given by the patient; (5) patients without distant metastasis. exclusion criteria: (1) those who did not undergo regular lt for various reasons, split lt, reduced-size lt, simultaneous transplantation, re-transplantation, multiple-organ recipients are excluded; (2) additional surgical procedures such as pancreaticoduodenectomy were performed; (3) those with other diseases such as active pulmonary tuberculosis, coronary heart disease, renal insufficiency and so on, which affect the therapeutic effect; (4) extensive abdominal metastasis was found during operation; (5) serious consequences or deaths caused by anesthesia accident during operation; (6) postoperative death due to other diseases such as traffic accidents, cardiovascular and cerebrovascular accidents; (7) with distant metastasis before operation.
an open label evaluation of the safety and pharmacokinetics of ganciclovir in children

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). to determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir iv in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * topical acyclovir. * consult with the syntex study monitor for the following: * cytokines. * soluble cd4. * trichosanthin (compound q). * imipenem-cilastatin. * other investigational drugs. patients must have the following: * congenital or acquired immune deficiency. * eligibility to receive ganciclovir for the treatment of life- or sight-threatening cytomegalovirus (cmv) disease. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * mild to moderate cytomegalovirus infection that does not satisfy the clinical severity criteria. * congenital or neonatal cmv infections without documented congenital or acquired immunodeficiency. concurrent medication: excluded: * other myelosuppressive drugs. * antimetabolites. * alkylating agents. * nucleoside analogs (topical acyclovir is allowed). * interferons. * foscarnet. * consult with the syntex study monitor for the following: * cytokines. * soluble cd4. * trichosanthin (compound q). * imipenem-cilastatin. * other investigational drugs. patients with the following are excluded: * mild to moderate cytomegalovirus (cmv) infection that does not meet the clinical severity criteria. * absolute neutrophil count (anc) \< 500 cells/mm3 or a platelet count \< 25000 platelets/mm3. note: * exceptions may be made for patients with pre-existing neutropenia or thrombocytopenia and immediately life-threatening disease, if the investigator believes that a delay in starting ganciclovir therapy is not advisable. in such patients, the investigator should advise the parents or guardians of the risk of further bone marrow suppression and the increased risk of infection or bleeding. * receiving excluded medications that it is not possible to discontinue. * congenital or neonatal cmv infections without documented congenital or acquired immunodeficiency. * demonstrated hypersensitivity to acyclovir or ganciclovir.

Keywords: retinitis ganciclovir cytomegalovirus infections acquired immunodeficiency syndrome immunocompromised host
study of the modification of the pharmacokinetic profile of levodopa by the fiber plantago ovata husk

Conditions: Parkinson's Disease, Idiopathic

Summary: the purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.

although the treatment with l-dopa is the election treatment for parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment. the origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. so that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of l-dopa in the circulation. the first experimental studies in animals showed that plantago ovata husk has an influence in the pharmacokinetics parameters of l-dopa, obtaining more stable levels.

Eligibility criteria:
inclusion criteria: * patients with diagnostic of idiopathic parkinson disease, with well controlled symptomatology with administration of l-dopa/carbidopa. * at least 3 months of treatment continued of levodopa. * patients that give the their consent to participate in the study. exclusion criteria: * patients with diagnostic of idiopathic parkinson disease, with bad controlled symptomatology with administration of l-dopa/carbidopa. * patients with allergic predisposition to plantago ovata husk or other contraindications for its use.

Keywords: parkinson's disease, idiopathic l-dopa levels plantago ovata husk
cardiac spect with rotating slant hole collimator

Conditions: Coronary Artery Diseases; Chest Pain

Summary: the goal is to conduct a clinical pilot study to evaluate the use of a rotating multi-segment slant-hole collimator in the detection of myocardial defects.

myocardial perfusion spect is recognized as an effective clinical diagnostic imaging technique in the assessment of myocardial perfusion and coronary artery diseases. it is the most important clinical application of spect imaging techniques. the goal is to conduct a clinical pilot study to evaluate the use of rotating multi-segment slant-hole (rmssh) spect in the detection of myocardial defects especially in very sick patients in the nuclear medicine clinics, emergence room, and intensive care units. comparison of the clinical utilities of the cardiac rmssh spect technique with conventional cardiac planar and spect with parallel-hole collimation will also allow us to evaluate the potential application of the technique to a wider patient population. the objective of this study is to test the hypothesis that quantitative 99mtc myocardial perfusion rmssh spect provides similar diagnostic accuracy in patients with cardiac diseases as conventional spect imaging techniques.

Eligibility criteria:
inclusion criteria: * males and females 18-80 who are scheduled for a clinical cardiac stress test exclusion criteria: * pregnant women and children

Keywords: myocardial perfusion spect
a hepatic impairment study for pf-04965842.

Conditions: Hepatic Impairment

Summary: this is a phase 1 non randomized, open label, single dose, parallel cohort study to investigate the effect of hepatic impairment on the pk, safety and tolerability of pf 04965842.

a minimum of 24 subjects with normal, mild or moderate hepatic function will be enrolled into the study, with approximately 8 subjects in each cohort. the child pugh classification score will be utilized to assess entry criteria and to assign subjects into the appropriate hepatic impairment group. for individual subjects, the total maximum duration of study participation from the screening visit to the end of clinical research unit (cru) stay is approximately 31 days and approximately 63 days from the screening visit to the follow up contact.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 pounds). * subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. additional inclusion criteria for subjects with hepatic impairment: * satisfy the criteria for class a or class b of the child pugh classification (mild: child pugh scores 5 to 6 points, and moderate: child pugh scores 7 to 9 points), within 14 days of investigational product administration. * a diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or magnetic resonance imaging (mri). exclusion criteria: * subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the investigator), evidence of any infection (including influenza) within the past 7 days, history of disseminated herpes simplex infection or recurrent (\>1 episode) or disseminated herpes zoster. * subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. additional exclusion criteria for subjects with hepatic impairment: * hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as less than 1 year). * subjects who have previously had a transplanted kidney, liver, or heart. * at screening, persistent severe, uncontrolled hypertension.